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Model Number MMT-105ELBLNA |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/09/2022 |
Event Type
malfunction
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Event Description
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Information received by medtronic indicated that the insulin pen had lead screw anomaly.Customer stated that the insulin was not dispensing when button was pushed.And screw was not moving when dose button was pushed.No harm requiring medical intervention was reported.Troubleshooting successfully performed and the customer will discontinue to use the insulin pen.
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Manufacturer Narrative
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Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Serial number: n/a.Software version: n/a.Color: blue.Battery life remaining: n/a.Per visual inspection: cap no longer stays attached and dosing window is missing.No physical damage to cartridge holder was noted.Customer reports: inpen is not dispensing insulin.Several attempts were made to pair inpen, every time app displayed dose doesn't match.The inpen does not pair with commercial mobile app.Inpen received with leadscrew 1/4 of the travel.Re-wound screw.No drag was observed, the screw was not bent, advanced when dosage knob was pressed dialing a dosage and retracted appropriately.No resistance was observed when dosing without a cartridge installed.The screw advanced every time 30.0u was dialed and dosed until the screw reached max extension.Inpen cap does not fit securely onto cartridge holder due to small snap arm cracked / broken.In conclusion: per san diego investigation: no transmission could not confirm eol.Disassembled pen and checked voltage (which was low at 1.2v).Therefore, the customers complaint of inpen not dispensing insulin is confirmed due inpen coming to its end of life.Inpen also did not transmit due to low battery voltage.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Search Alerts/Recalls
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